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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Regionshospitalet Silkeborg | OTHER |
| Randers Regional Hospital | OTHER |
| Regional Hospital Holstebro |
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The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal artery ablation | Active Comparator | By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to active treatment, renal artery ablation will be carried out straight away. |
|
| Sham | Sham Comparator | By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to sham procedure, no renal artery ablation are performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal artery ablation | Procedure | Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access. |
| Measure | Description | Time Frame |
|---|---|---|
| daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement | Changes in mean daytime systolic BP after 3 months is compared between groups. Also the proportion of responders versus nonresponders after 3 months is compared between groups, responders being defined as A) a minimum decrease in daytime systolic BP of 10 mmHg analysis together with and unchanged/increased number of antihypertensive drugs, or B) a decrease in daytime systolic BP of 0-10 mmHg together with a reduced number of antihypertensive drugs. | 3 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| ambulatory 24 hours BP measurements | Systolic, diastolic and mean Blood Pressures at different time points. Daytime and night time BP, dipping status, morning BP surge and BP variation. | 1, 3 and 6 months |
| Echocardiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ole N Mathiassen, MD, PhD | Aarhus University Hospital, Dep. Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skejby Hospital | Aarhus | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28830251 | Derived | Peters CD, Mathiassen ON, Vase H, Bech Norgaard J, Christensen KL, Schroeder AP, Rickers HJVH, Opstrup UK, Poulsen PL, Langfeldt S, Andersen G, Hansen KW, Botker HE, Engholm M, Bertelsen JB, Pedersen EB, Kaltoft A, Buus NH. The effect of renal denervation on arterial stiffness, central blood pressure and heart rate variability in treatment resistant essential hypertension: a substudy of a randomized sham-controlled double-blinded trial (the ReSET trial). Blood Press. 2017 Dec;26(6):366-380. doi: 10.1080/08037051.2017.1368368. Epub 2017 Aug 23. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Central Jutland Regional Hospital | OTHER |
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| Renal angiography | Procedure | Renal angiography by femoral access. |
|
Coronary flow reserve (LAD), Diastolic and Systolic ventricular function. LV hypertrophy.
| 6 months |
| Biomarkers | Biomarkers concerning renal sodium excretion | 1 months |
| Applanation tonometry | Pulse wave velocity, augmentation index, central BP estimates | 6 months |
| forearm plethysmography | Forearm minimum vascular resistance | 6 months |